Precision Neuroscience scored a big win with the US Food and Drug Administration 510(k) clearance of a core component of its implantable, wireless brain computer interface system designed to enable users with severe paralysis to operate digital devices, such as computers and smartphones, using only their thoughts.
Specifically, the FDA cleared Precision’s Layer 7 Cortical Interface, a high-resolution cortical electrode array used to record, monitor and stimulate electrical activity on the surface of the brain.
The array is a core component of Precision’s fully implantable, wireless brain-computer interface system, currently in development. The implant features 1,024 ultra-thin electrodes distributed across film that measures 1.5 square centimeters, about the size of a fingernail. The agency cleared Layer 7 Cortical Interface as a temporary implant for 30 days, allowing it to be used for weeks rather than just hours and “opening up new possibilities for scientific discovery,” the New York-based firm said.
“The clearance represents a major milestone for the brain-computer interface field, as it marks the first full regulatory clearance granted to a company developing a next-generation wireless BCI,” said Benjamin Rapoport, chief science officer and co-founder at Precision Neuroscience. “By introducing the Layer 7 Corticol Interface into clinical settings, we’ll be able to deliver immediate value for patients and neurosurgical teams, enabling real-time neural recording at a fidelity and scale not previously possible.”
Rapoport said that the extended implant duration will allow Precision to exponentially increase access to high-quality data, which will help the company build BCI systems that work more effectively. The clearance also allows Precision to begin marketing its technology for clinical applications, such as intraoperative brain mapping.
Naveen Rao, editor-in-chief of Neurotech Futures, a market intelligence platform and managing partner at business intelligence practice Patchwise Labs, considers the FDA clearance a major step forward in validating the need for next-generation interfaces.
“But more importantly, the clearance creates a much more ethical, safer and humane option for researchers to use, compared to higher-risk intracortical arrays that are relics of previous decades,” Rao told Medtech Insight.
The device has been tested in 37 patients across prominent research institutions including Mount Sinai Health System, the Perelman School of Medicine at the University of Pennsylvania, West Virginia University’s Rockefeller Neuroscience Institute and Beth Israel Deaconess Medical Center.
But more importantly, the clearance creates a much more ethical, safer and humane option for researchers to use, compared to higher-risk intracortical arrays that are relics of previous decades." -- Naveen Rao
For instance, at Beth Israel Deaconess Medical Center, a leading teaching hospital affiliated with Harvard Medical School, the implant was used to record and analyze brain activity in patients undergoing craniotomy procedures, Precision Neuroscience announced on 27 February.
The company now plans to expand its clinical research program. Rao expects that these clinical partnerships will accelerate their commercial development. He quoted Rapaport, who told Rao last summer that “You don’t start a company to do new science. You start a company to do things that can’t be done in an academic setting.”
In December 2024, Precision closed a $102m series C funding round led by General Equity Holdings with participation from B Capital, Duquesne Family Office and Steadview Capital, bringing its total funding raised to $155m. The company then said that it would use the funding to expand its team, advance clinical research efforts and refine future versions of its brain implant.
Michael Mager, the company’s co-founder and CEO, said in a statement that Precision’s roadmap extends beyond motor paralysis.
“We’re beginning to address some of the most debilitating disorders – severe spinal cord injury, stroke, ALS – and our goal is to develop a product that is safe enough, and scalable enough, to treat a broad range of neurological conditions,” Mager said.
Rao expects that the company will develop a commercial portfolio that includes permanent implants in years ahead.
